Food Safety Network

Genetically Engineered Soybeans in Canada

29.oct.02, Food Safety Network Fact Sheet, Food Safety Network Fact Sheet

In Canada, responsibility for health and environmental safety of products of genetic engineering is divided primarily among four departments. Health Canada is responsible for approving crops for food use and food labelling with respect to health and safety matters. The Canadian Food Inspection Agency conducts safety assessments on fertilizers, seeds, plants, animals, animal vaccines and livestock feed. Fisheries and Oceans Canada is responsible for regulating fish and Environment Canada under the Canadian Environmental Protection Act ensures the products are assessed, unless they are assessed under other legislation.

Canada's Novel Food Regulations require developers of novel foods, including foods derived from genetic engineering, to notify the Health Canada prior to the sale or advertising for sale of the novel foods in Canada. The required safety assessment of food developed using genetic engineering (modification) includes the evaluation of the process used to develop it; the comparison of its characteristics to that of the traditional counterpart; the nutritional quality and the potential for the presence of any toxicants or anti-nutrients; and the potential allergenicity resulting from any proteins introduced into the food. This assessment provides assurances that the safety of a novel food is equivalent to similar foods already available in the Canadian marketplace. Once reviewed by Health Canada, these foods can enter the marketplace in the same manner as traditional foods and be subjected to the same post-market standards applicable to all foods sold in Canada. Mandatory labelling is required for genetically modified foods where safety concerns such as allergenicity and compositional or nutritional changes are identified. In this situation, labelling will be required to alert consumers or susceptible groups in the population.

Genetically engineered soybeans approved by Health Canada are herbicide tolerant or have a change in their fatty acid composition. An extensive assessment of the soybeans was conducted by Health Canada according to the Guidelines for Safety Assessment of Novel Foods before an approval for human food use. The assessment compares soybeans with the commercial variety from which they were derived, as well as with other commercial varieties of soybeans.

Health Canada's Guidelines for the Safety Assessment of Novel Foods (including those foods developed from genetic modification) are based upon scientific principles developed through expert international consultation with agencies such as the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO) and the Organisation for Economic Co-operation and Development (OECD). The approach to the safety assessment of biotechnology-derived foods taken by Canada is currently applied by regulatory agencies around the world in countries such as the European Union, Australia/New Zealand, Japan, and the United States.

Soybean varieties genetically engineered to tolerate in-crop applications of herbicide have an extra gene which comes from common soil bacteria. The inserted gene in the soybean produces a new enzyme, a protein which is easily digested by humans. Health Canada determined that, apart from minute levels of the introduced protein, there is no difference between the genetically modified soybeans and other commercial varieties. The insertion of genetic information into these soybeans to confer herbicide tolerance causes no difference in the nutritional quality of the soybeans. Health Canada stated that assessments for potential allergenicity or potential toxicity did not raise concerns.

Soybeans with a change in their fatty acid composition are used to produce oil with higher levels of oleic acid. This is intended to improve the heat stability of the oil for food applications such as frying. A second copy of a gene already found in the soybean is inserted, which causes the native gene to be shut off and an enzyme normally in the soybean is no longer present. There are no new proteins expressed in high oleic acid soybeans. With the exception of the fatty acid profile, no nutrient differences were determined for the high oleic acid soybean compared to non-genetically modified soybean. Allergenicity and toxicity assessments indicated that there were no significant differences between the high oleic soybean and non-modified soybean.

The Plant Biosafety Office of the Canadian Food Inspection Agency (CFIA) is responsible for the regulation of plants with novel traits, including those derived from genetic engineering, with respect to environmental safety. The CFIA carries out safety assessments to evaluate new agricultural products for their efficacy and the safety of the workers/bystanders, animals and the environment. The CFIA is also involved in post-approval inspection.

Environmental release of plants with novel traits in Canada requires authorization by the CFIA. Authorizations are issued only after an environmental risk assessment has been conducted by the Plant Biosafety Office. When a developer wishes to release a plant with a novel trait into the environment, they must provide detailed information about the novel trait, the method used to introduce the novel trait into the plant and any risks of adverse environmental effects resulting from the release of the plant into the environment. Potential adverse effects could include the plant becoming a weed of agriculture or invasive of natural habitats; novel traits passing to wild relatives through gene flow; the plant or its gene products adversely effecting non-target organisms (including humans); and the plant's impact on biodiversity.

The CFIA reviewed the data and information submitted by the developers of the varieties of genetically engineered soybeans and compared them with their unmodified soybean counterparts. In each case, the CFIA determined that neither the inserted gene nor its resulting gene product and associated novel trait confers any intended or unintended ecological advantage, or environmental impact, to the soybean. The potential for transfer of the herbicide-resistance trait to other soybean plants is very low, due to the biology of the species. There is no potential for transfer to wild relatives. In addition, CFIA has concluded that the novel gene and its corresponding trait do not raise any concerns regarding the safety or nutritional composition as animal feed.

In Ontario, estimates for 2002 plantings from sales figures and commodity groups show that 40-50% of soybeans are genetically engineered, up from 25-30% in 2001. According to researchers, farmers choose to grow soybeans genetically engineered to tolerate herbicides to take advantage of the benefits of broad spectrum weed control, crop safety, flexible treatment timing and cost savings. Herbicide tolerant crops can be used in a no- or minimal-till system to help reverse decades of soil erosion.

For more information, please contact Dr. Douglas Powell at (519) 821-1799.

Information Sources

AGCare. (2002, July 15). Ontario use of biotech crops on the increase again. Retrieved October 29, 2002, from http://www.agcare.org/new.cfm?documentid=17

Canadian Food Inspection Agency. (2002). Plant Biosafety Office. Retrieved October 29, 2002, from http://www.inspection.gc.ca/english/plaveg/pbo/pbobbve.shtml

Canadian Food Inspection Agency. (2001). The Safety of biotechnology-derived food crops. Retrieved October 29, 2002, from http://www.inspection.gc.ca/english/ppc/biotech/safsal/safsale.shtml

Canadian Food Inspection Agency. (2002). Status of regulated plants with novel traits in Canada: Unconfined environmental release, novel livestock feed use, variety registration and novel food use. Retrieved October 29, 2002, from http://www.inspection.gc.ca/english/plaveg/pbo/dd/dd9505e.shtml#A17

Gianessi, L.P., & J.E. Carpenter (2000). Agricultural Biotechnology: Benefits of transgenic soybeans. Retrieved October 29, 2002, from http://www.ncfap.org/reports/biotech/rrsoybeanbenefits.pdf

Health Canada. (2002). Food Program: Novel foods and ingredients. Retrieved October 29, 2002, from

http://www.hc-sc.gc.ca/food-aliment/mh-dm/ofb-bba/nfi-ani/e_novel_foods_and_ingredient.html